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1,3-Beta-D-Glucan (Fungitell), Serum

Test ID: SFUNG S

Test

Method

Protease Zymogen-Based Colorimetric Assay

Method Description

The Fungitell assay measures levels of (1,3)-beta-D-glucan (BDG). The assay is based upon a modification of the limulus amebocyte lysate (LAL) pathway. The Fungitell reagent is modified to eliminate factor C and, thus, to only react to BDG, through the factor G-mediated side of the pathway. BDG activates factor G, a serine protease zymogen. The activated factor G converts the inactive proclotting enzyme to the active clotting enzyme, which in turn cleaves pNA from the chromogenic peptide substrate, Boc-Leu-Gly-Arg-pNA, creating a chromophore that absorbs at 405 nm. The Fungitell kinetic assay is based upon the determination of the rate of optical density (OD) increase produced by a sample. This rate is interpreted against a standard curve to produce estimates of BDG concentration in the sample.(Package insert: Assay for [(1,3]-Beta-D-Glucan in Serum. Associates of Cape Cod Inc; 02/2011)

Report Includes

1,3-Beta-D-Glucan (Fungitell)

Specimens

Serum

Clinical Utility

Aiding in the diagnosis of invasive fungal infections caused by various fungi, including Aspergillus species, Fusarium species, Candida species, and Pneumocystis jiroveccii, among others.

Test Location

MN, USA

Test Version

15-Jan-2021

Specimen

Specimens

Serum

Collection Containers

Serum gel (red top tube is not acceptable)

Sample Volume

1 mL

Minimum Volume

0.5 mL

Collection & Handling

Collection Instructions

Collect specimen in gel-separator tube.

Handling Information

Avoid exposure of specimen to atmosphere to prevent environmental contamination of the sample. Centrifuge and send specimen in original collection tube. Do not aliquot or open tube.

Stability

Refrigerated 14 days
Frozen 30 days

Rejection Criteria

Hemolysis Gross
Lipemia Gross
Icterus Gross
Specimen Plain red top

Test Version

15-Jan-2021

Performance / Interpretation

Method

Protease Zymogen-Based Colorimetric Assay

Method Description

The Fungitell assay measures levels of (1,3)-beta-D-glucan (BDG). The assay is based upon a modification of the limulus amebocyte lysate (LAL) pathway. The Fungitell reagent is modified to eliminate factor C and, thus, to only react to BDG, through the factor G-mediated side of the pathway. BDG activates factor G, a serine protease zymogen. The activated factor G converts the inactive proclotting enzyme to the active clotting enzyme, which in turn cleaves pNA from the chromogenic peptide substrate, Boc-Leu-Gly-Arg-pNA, creating a chromophore that absorbs at 405 nm. The Fungitell kinetic assay is based upon the determination of the rate of optical density (OD) increase produced by a sample. This rate is interpreted against a standard curve to produce estimates of BDG concentration in the sample.(Package insert: Assay for [(1,3]-Beta-D-Glucan in Serum. Associates of Cape Cod Inc; 02/2011)

Turnaround Time

5 days

Results

Name Units Reference Range Conversion Factor
Fungitell Quantitative Value pg/mL
  • <60
Fungitell Qualitative Result
  • Negative
This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3) Beta-D-Glucan (BDG) and the Zygomycetes (e.g., Absidia, Mucor and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay. This assay was performed using the FDA-cleared Fungitell Assay (Associates of Cape Cod, East Falmouth, MA, USA), a kinetic ELISA based on modification of the Limulus Amebocyte Lysate pathway.

Test Location

MN, USA

Test Version

15-Jan-2021

Interface / Setup

HL7 Interface Codes

Order Code Result Codes Units
SFUNG S 63356Fungitell Quantitative Value pg/mL
63357Fungitell Qualitative Result

Test Version

15-Jan-2021